[go: up one dir, main page]

ECSP15051434A - LOW DOSE PHARMACEUTICAL COMPOSITION - Google Patents

LOW DOSE PHARMACEUTICAL COMPOSITION

Info

Publication number
ECSP15051434A
ECSP15051434A ECIEPI201551434A ECPI201551434A ECSP15051434A EC SP15051434 A ECSP15051434 A EC SP15051434A EC IEPI201551434 A ECIEPI201551434 A EC IEPI201551434A EC PI201551434 A ECPI201551434 A EC PI201551434A EC SP15051434 A ECSP15051434 A EC SP15051434A
Authority
EC
Ecuador
Prior art keywords
pharmaceutical composition
deferasirox
low dose
dose pharmaceutical
composition comprises
Prior art date
Application number
ECIEPI201551434A
Other languages
Spanish (es)
Inventor
Shrinivas Madhukar Purandare
Geena Malhotra
Original Assignee
Cipla Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cipla Ltd filed Critical Cipla Ltd
Publication of ECSP15051434A publication Critical patent/ECSP15051434A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/04—Chelating agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Esta invención proporciona una composición farmacéutica de dosis baja que comprende deferasirox o un derivado farmacéuticamente aceptable del mismo y uno o más excipientes farmacéuticamente aceptables. Una dosis unitaria de la composición farmacéutica comprende desde aproximadamente 50 mg hasta aproximadamente 100 mg de deferasirox, desde aproximadamente 150 mg hasta aproximadamente 200 mg de deferasirox o desde aproximadamente 260 mg hasta aproximadamente 350 mg de deferasirox. La composición farmacéutica de la presente invención, en la que la composición farmacéutica comprende deferasirox, puede usarse para tratar sobrecarga de hierro crónica o para tratar toxicidad por plomo. La composición farmacéutica de la presente invención, en la que la composición farmacéutica comprende deferasirox y deferiprona, puede usarse para tratar toxicidad por plomo. Esta invención también proporciona un procedimiento para preparar la composición farmacéutica de dosis baja, comprendiendo el procedimiento: disolver o adsorber o combinar deferasirox y al menos un excipiente para producir una dispersión de deferasirox; y procesar la dispersión para producir una forma de dosificación deseada.This invention provides a low dose pharmaceutical composition comprising deferasirox or a pharmaceutically acceptable derivative thereof and one or more pharmaceutically acceptable excipients. A unit dose of the pharmaceutical composition comprises from about 50 mg to about 100 mg of deferasirox, from about 150 mg to about 200 mg of deferasirox, or from about 260 mg to about 350 mg of deferasirox. The pharmaceutical composition of the present invention, wherein the pharmaceutical composition comprises deferasirox, can be used to treat chronic iron overload or to treat lead toxicity. The pharmaceutical composition of the present invention, wherein the pharmaceutical composition comprises deferasirox and deferiprone, can be used to treat lead toxicity. This invention also provides a process for preparing the low dose pharmaceutical composition, the process comprising: dissolving or adsorbing or combining deferasirox and at least one excipient to produce a dispersion of deferasirox; and processing the dispersion to produce a desired dosage form.

ECIEPI201551434A 2013-05-10 2015-12-10 LOW DOSE PHARMACEUTICAL COMPOSITION ECSP15051434A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN1696MU2013 IN2013MU01696A (en) 2013-05-10 2014-05-08

Publications (1)

Publication Number Publication Date
ECSP15051434A true ECSP15051434A (en) 2017-05-31

Family

ID=50979804

Family Applications (1)

Application Number Title Priority Date Filing Date
ECIEPI201551434A ECSP15051434A (en) 2013-05-10 2015-12-10 LOW DOSE PHARMACEUTICAL COMPOSITION

Country Status (18)

Country Link
US (4) US20160120847A1 (en)
EP (1) EP2994131A1 (en)
JP (1) JP2016518398A (en)
CN (1) CN105377256A (en)
AP (1) AP2015008875A0 (en)
AU (1) AU2014264421A1 (en)
BR (1) BR112015028257A2 (en)
CA (1) CA2911671A1 (en)
EC (1) ECSP15051434A (en)
HK (1) HK1215191A1 (en)
IN (1) IN2013MU01696A (en)
MX (1) MX2015015553A (en)
PE (1) PE20151934A1 (en)
PH (1) PH12015502557A1 (en)
RU (1) RU2015149544A (en)
SG (1) SG11201509308TA (en)
WO (1) WO2014181108A1 (en)
ZA (1) ZA201403276B (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3310354A4 (en) 2015-06-17 2018-12-12 Dispersol Technologies, LLC Improved formulations of deferasirox and methods of making the same
RU2616267C1 (en) * 2016-01-25 2017-04-13 Закрытое Акционерное Общество "БИОКОМ" Solid drug form of indinavir with immediate release and method of obtaining thereof
US20190091204A1 (en) * 2016-03-17 2019-03-28 Lupin Limited Compositions of deferasirox
CN105853367B (en) * 2016-05-10 2019-07-12 广州加德恩医药有限公司 Preparation method of deferasirox solid dispersion and pharmaceutical preparation thereof
CA3029543C (en) * 2016-07-05 2021-11-23 Jubilant Generics Limited Immediate release pharmaceutical composition of iron chelating agents
CZ2017255A3 (en) * 2017-05-04 2018-11-14 Zentiva, K.S. Film-coated Deferasirox tablets
WO2018230713A1 (en) * 2017-06-16 2018-12-20 学校法人同志社 Compounds having caspase inhibitory activity, pharmaceutical agent containing said compounds and for treating or preventing corneal endothelial symptoms, disorders, or diseases, and application of said pharmaceutical agent
WO2018230711A1 (en) 2017-06-16 2018-12-20 学校法人同志社 Mtor-inhibitor-containing medicine for treating or preventing ophthalmic symptoms, disorders, or diseases, and application thereof
SG11202003153TA (en) * 2017-10-25 2020-05-28 Chiesi Farm Spa Delayed release deferiprone tablets and methods of using the same
CN109646423A (en) * 2018-12-03 2019-04-19 泓博元生命科技（深圳）有限公司 Boiomacromolecule nanosphere containing NADH and the preparation method and application thereof
CN115400088B (en) * 2022-09-06 2023-07-07 上海奥科达医药科技股份有限公司 Dila Luo Siyao composition and preparation method thereof
CN115154428B (en) * 2022-09-06 2023-01-10 上海奥科达医药科技股份有限公司 Deferasirox pharmaceutical composition and preparation method thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW533205B (en) * 1996-06-25 2003-05-21 Novartis Ag Substituted 3,5-diphenyl-l,2,4-triazoles and their pharmaceutical composition
GB0223978D0 (en) 2002-10-15 2002-11-20 Novartis Ag Organic compound
GB0408078D0 (en) 2004-04-08 2004-05-12 Novartis Ag Organic compounds
JP2009512652A (en) 2005-10-19 2009-03-26 ノバルティス アクチエンゲゼルシャフト Dispersed tablets containing benzoic acid derivatives
WO2009016359A1 (en) * 2007-07-27 2009-02-05 Pliva Hrvatska D.O.O. New forms of deferasirox
US20090142395A1 (en) * 2007-11-19 2009-06-04 Uri Zadok Deferasirox pharmaceutical compositions
WO2010035282A1 (en) 2008-09-24 2010-04-01 Matrix Laboratories Limited Pharmaceutical compositions comprising deferasirox
NZ608380A (en) * 2010-10-01 2014-10-31 Cipla Ltd Pharmaceutical composition comprising deferasirox
JP2014529997A (en) * 2011-09-23 2014-11-17 ウニヴェルズィテート シュトゥットガルト Serum half-life extension using immunoglobulin binding domains

Also Published As

Publication number Publication date
RU2015149544A (en) 2017-06-16
HK1215191A1 (en) 2016-08-19
MX2015015553A (en) 2016-06-17
CA2911671A1 (en) 2014-11-13
JP2016518398A (en) 2016-06-23
ZA201403276B (en) 2015-07-29
CN105377256A (en) 2016-03-02
EP2994131A1 (en) 2016-03-16
SG11201509308TA (en) 2015-12-30
US20160120847A1 (en) 2016-05-05
PE20151934A1 (en) 2015-12-26
AP2015008875A0 (en) 2015-11-30
US20170312254A1 (en) 2017-11-02
US20160158202A1 (en) 2016-06-09
AU2014264421A1 (en) 2015-12-03
PH12015502557A1 (en) 2016-02-22
US20170095453A1 (en) 2017-04-06
IN2013MU01696A (en) 2015-06-26
WO2014181108A1 (en) 2014-11-13
BR112015028257A2 (en) 2017-07-25

Similar Documents

Publication Publication Date Title
ECSP15051434A (en) LOW DOSE PHARMACEUTICAL COMPOSITION
ZA202308495B (en) Pharmaceutical compositions of therapeutically active compounds
DOP2019000201A (en) HIV INHIBITING COMPOUNDS
CO2020004301A2 (en) 1-Benzyl-2-imino-4-phenyl-5-oxoimidazolidine derivatives as hiv protease inhibitors
PH12018501807A1 (en) Pyrazolopyrrolidine derivatives and their use in the treatment of diseas
MX2015016344A (en) Imidazopyrrolidinone derivatives and their use in the treatment of disease.
GT201500053A (en) PHARMACEUTICAL COMPOSITION COVERED WITH REGORAFENIB
MX2015016421A (en) Pyrazolo-pyrrolidin-4-one derivatives as bet inhibitors and their use in the treatment of disease.
PH12016501788B1 (en) Pharmaceutical compositions of therapeutically active compounds
MX2016008665A (en) 1,2-naphthoquinone derivative and method for preparing same.
MX2018003256A (en) Mono- or di-substituted indole derivatives as dengue viral replication inhibitors.
MX368903B (en) THERAPEUTIC COMPOUNDS and USES THEREOF.
ECSP16084317A (en) PHARMACEUTICAL FORMULATIONS, PREPARATION PROCESSES AND METHODS OF USE
MX2016008429A (en) DERIVED FROM PIRANOCROMENIL PHENOL, AND PHARMACEUTICAL COMPOSITION TO TREAT A METABOLIC SYNDROME OR INFLAMMATORY DISEASE.
AR101674A1 (en) USE OF A TRICYCLIC COMPOUND CONTAINING NITROGEN
MX381440B (en) PHARMACEUTICAL COMPOSITION FOR TREATMENT OF ULCERATIVE COLITIS.
AR094707A1 (en) COMPOUND OF QUINAZOLIN-4-AMINA, PHARMACEUTICAL COMPOSITION THAT INCLUDES IT AND ITS USE FOR THE TREATMENT OF A DISEASE MEDIATED BY THE RIP2 KINASE
AR095032A1 (en) FORMULATIONS OF ORGANIC COMPOUNDS, SOLID PHARMACEUTICAL COMPOSITION COMPRESSED BY ROLLER
EA202091169A1 (en) SMAC MIMETICS USED AS IAP INHIBITORS AND THEIR APPLICATION
MX2017013103A (en) METHODS FOR THE TREATMENT OF CARDIOVASCULAR DISORDERS.
ZA201606135B (en) Pharmaceutical compositions of therapeutically active compounds